FDA Adverse Event
Malfunction
Summary report: N
SENSOR ENLITE
MDR report key: 4150362
·
Received October 7, 2014
Report
- Report Number
- 2032227-2014-35033
- Event Type
- Malfunction
- Date Received
- October 7, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND AND RETURNED A SENSOR ERROR. CUSTOMER REPORTED THAT SHE RECEIVED A WARNING THAT HER SENSOR GLUCOSE LEVEL WAS APPROACHING 40 MG/DL. HOWEVER, THE BLOOD GLUCOSE LEVEL WAS 275 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628753 | SENSOR ENLITE | OZO | OZO | MEDTRONIC MINIMED | MMT-7008A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |